FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/08/020617 [Registered on: 07/08/2019] Trial Registered Prospectively
Last Modified On: 06/08/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Electrolyte supplementation]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of early sodium supplementation in postnatal weight gain of preterm babies. 
Scientific Title of Study   Effect of early sodium supplementation on postnatal weight gain at 34 weeks of postmenstrual age in preterm babiesborn between 25 to 31 weeks gestation age : A Double blinded Randomized controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anvesh Amiti 
Designation  DM (Neonatology) resident 
Affiliation  Sri Ramachandra institute of Higher Education and Research 
Address  C3 NICU, Main block, Sri Ramachandra medical center, Porur, Chennai, Tamilnadu.

Chennai
TAMIL NADU
600116
India 
Phone  8074662493  
Fax    
Email  anvesh.swathi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prakash A 
Designation  HOD Neonatology SRIHER 
Affiliation  SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH CENTRE 
Address  C3 NICU, Main block, Sri Ramachandra medical center, Porur, Chennai, Tamilnadu.

Chennai
TAMIL NADU
600116
India 
Phone  9791181566  
Fax    
Email  draprakash1@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Prakash A 
Designation  HOD Neonatology SRIHER 
Affiliation  SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH CENTRE 
Address  C3 NICU, Main block, Sri Ramachandra medical center, Porur, Chennai, Tamilnadu.

Chennai
TAMIL NADU
600116
India 
Phone  9791181566  
Fax    
Email  draprakash1@gmail.com  
 
Source of Monetary or Material Support  
Departmental (neonatology) research fund,SRIHER 
 
Primary Sponsor  
Name  Department of Neonatology Sri Ramachandra Institute of Higher Education and Research 
Address  No.1, Sri Ramachandra Nagar, Porur, Chennai 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Anvesh Amiti  SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH CENTRE  Department of neonatology, neonatal intensive care unit, room no C3 and G3
Chennai
TAMIL NADU 
8074662493

anvesh.swathi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri ramachandra institute of higher education and research Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P742||Disturbances of sodium balance ofnewborn,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  0.45% saline  Control group which will receive 0.45% saline(commercially available) also kept as 10 ml aliquots.While infants in the placebo arm received the same volume of sterile 0.45%NS divided equal volume in 12 feeds daily 
Intervention  15% hypertonic saline  Study drug will be prepared by the pharmacist under strict aseptic conditions using laminar flow by adding analytic sodium to sterile water to make the desired concentration of 15% saline.The study drug will be initiated after obtaining consent from parents, when baby reaches 100TCI of feeds and administered with every feed upto 34 weeks PMA.Infants randomized to the intervention arm receive of 15% sodium chloride for a total of 4 mEq/ kg/d in divided equal volume in 12 feeds daily 
 
Inclusion Criteria  
Age From  5.00 Day(s)
Age To  9.00 Day(s)
Gender  Both 
Details  25 + 0 weeks to 30+6 weeks gestation age 
 
ExclusionCriteria 
Details  1) major malformations incompatible with life
2) Congenital gastrointestinal anomalies
3) Clinical condition warranting NPO
4) Renal insufficiency or disease states (such as hydrops fetalis) that are characterized by edema.
5) Enrolled infants with most recent serum sodium concentrations >145 mmol/L on day of recruitment were excluded. 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
weight gain /kg/day   at 34 weeks of PMA 
 
Secondary Outcome  
Outcome  TimePoints 
Length and head circumference
Time to reach birth weight
BPD
PDA
ROP
PVL
Duration of hospital stay
Necrotising enterocolitis
Requirement of Nacl for treatment hyponatremia.  
at 34 weeks of PMA 
 
Target Sample Size   Total Sample Size="104"
Sample Size from India="104" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   12/08/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

The burden of hyponatremia: Infants born at <28 weeks’ GA the incidence of hyponatremia was 64%. Infants born between 29 to 34 weeks the incidence between 33%–70%


Why hyponatremia in preterm: At the time when the majority of preterm infants are born, renal development is still ongoing and renal function is accordingly immature. Preterm neonates have been shown to have a low glomerular filtration rate (GFR) compared with term neonates, and the tubules excrete high amounts of sodium. Furthermore, compared with babies born at term, preterm neonates may demonstrate a slower progression in renal functional maturation after birth.


Proposed Mechanism Accounting for Impaired Growth in Sodium Deficiency: More than 20 years ago Haycock described a mechanism accounting for sodium regulation of cellular growth, attributing it to the Na–H antiporter. This pathway is now widely accepted as an important regulator of tumour cell growth and likely plays an important role in sodium deficiency-induced growth impairment. Activation of the antiporter leads to an increase in intracellular pH and is essential, or at least permissive, for the development of a cell proliferative response. Reduced extracellular sodium availability inhibits hydrogen extrusion, and thus promoting intracellular acidosis and this is the mechanism responsible for the impaired growth receptors’ function.


Other problems with hyponatremia: Neonate with hyponatremia had longer hospital stays and higher risks of BPD and ROP

requiring treatment.Hyponatremia lasting at least 7 days significantly associated with periventricular leukomalacia, and extra-uterine growth retardation.


Importance of oral sodium supplementation: Growth in the early neonatal period in premature infants affects neurodevelopmental

outcomes. Sodium is important for growth, yet fortified human milk and commercial formulas often fail to provide the 3–7 mEq/kg/d current sodium intake recommendations for preterm infants.


Need for our study: Though sodium level has implications on short and long term outcomes, there is no consensus worldwide. There are no trials in India regarding routine sodium supplementation in preterm to the best of our knowledge.


Methodology: Study drug will be prepared by the pharmacist under strict aseptic conditions using laminar flow by adding analytic sodium to sterile water to make the desired concentration of 15% saline Preparation of drug planned to do biweekly by the pharmacist. The prepared drug will store in 10ml syringes at room temperature. (we checked for stability, the drug does not have any precipitation or physical changes)Control group which will receive 0.45% saline(commercially available) also keep as 10

ml aliquots. The study drug was initiated after obtaining consent from parents when the baby reaches 100TCI of feeds and administered with every feed up to 34 weeks PMA. Infants randomized to the intervention arm receive of 15% sodium chloride for a total of 4 mEq/ kg/d in divided equal volume in 12 feeds daily. While infants in the placebo arm received the same volume of sterile 0.45%NS divided the equal volume into 12 feeds daily. Started with dosage based on weight at birth. After crossing birthweight dose will change every 3rd day as per on working weight. 1st sodium sampling will be done when the neonate reaches100TCI between day 5 to 9, and if value <145 will include in the study. After reaching 100 TCI if sodium >145 then will do daily sodium monitoring until day 9. After day 9 still sodium >145 then the neonate will be excluded from study. After starting study 1st sample will be done between 3 to 5 days, later all samples will be done on every Sundays. Comprehensive and weekly weight gain velocities (g/kg/d) were calculated. Weight, length, and head circumference measurements at birth and weekly until 34 weeks PMA will be plotted on Fenton growth charts

 
Close